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Completed

NCT Number: NCT02413762

The Role of Gut Hormones and Hepcidin in Type 2 Diabetes Mellitus

This study aims to investigate the potential of the gut hormones GLP-1, PP, PYY and the iron regulatory hormone hepcidin as biomarkers for progression to complications in diabetes mellitus.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College London Diabetes Centre

Abu Dhabi, 48338, United Arab Emirates

About this study

Iron overload and mechanisms inducing insulin resistance are reciprocally linked. Dietary iron absorption, and iron uptake in liver and adipose tissue, are regulated through the hormone hepcidin. Iron is implicated in microvascular and macrovascular disease pathways and therefore hepcidin may represent a biomarker for progression to complications in type 2 diabetes mellitus.

Serum pancreatic polypeptide levels correlate with visceral adiposity and may therefore contribute to the diagnosis of, and risk stratification in, the metabolic syndrome.

Hypothesis:

Measuring iron status, incretin hormones and serum pancreatic polypeptide will facilitate discrimination of patients at risk of vascular complications of T2DM and clinically significant non-alcoholic fatty liver disease.

Statistical analysis:

Serum/plasma level of hormone under investigation corrected for age, sex, BMI, diabetes duration, blood pressure, lipid profile, smoking status, treatment for diabetes, hypertension and dyslipidaemia, and HbA1c using multinomial logistic regression and Cox regression models.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all

Exclusion criteria

  • lack of capacity for informed consent; vulnerable individuals

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Microvascular complication of diabetes mellitus - prevalence and incidence

    Time frame: 5 years

    Prevalence at enrolment and subsequent incidence of background diabetic retinopathy, preproliferative or proliferative retinopathy, or diabetic maculopathy; microalbuminuria defined as two episodes > 3 months apart of ACR > 2.5 (male) or > 3.5 (female) mg/umol. Assessed through patient recall and examination of electronic medical record.

  2. Macrovascular complication of diabetes mellitus - prevalence and incidence

    Time frame: 5 years

    Prevalence at enrolment and subsequent incidence of composite endpoint of coronary artery disease (MI, ACS, percutaneous intervention), cerebrovascular disease (CVA, TIA), and peripheral arterial disease (ischaemic peripheral ulcer, revascularisation procedure, amputation). Assessed through patient recall and examination of electronic medical record.

Secondary outcomes

  1. Progression to NAFLD or NASH

    Time frame: 5 years

    As defined by ultrasound criteria of NAFLD or evidence of fibrosis as measured using transient elastography, respectively

Sponsors and collaborators

Lead sponsor

Imperial College London Diabetes Centre

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2022
First posted
Apr 10, 2015
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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